Recruiting

Metabolic Pathways

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05296421

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Therapeutic Conventional Surgery

Uniformly-labeled [13C]glucose

Study Details

Brief summary:

This clinical trial investigates the nutrients pancreatic cancers depend on in which to survive and the processes these tumors use (metabolism) to obtain these nutrients. Giving U-13C-glucose during surgery may allow doctors to trace the metabolic activity of pancreatic cancer in research experiments done in the laboratory. These experiments may help researchers understand how cancer cells manage their nutrients when compared to normal pancreatic cells.

Conditions

Pancreatic Ductal Adenocarcinoma

Study ID

NCT05296421

Start date

Mar 14, 2022

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients >= 18 years of age
  • Pancreatic adenocarcinoma patients, previously diagnosed by biopsy, who are candidates for intended curative resection either with or without neoadjuvant chemotherapy
  • Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed pancreatectomy
  • 16 patients will be enrolled including 8 with no prior treatment and 8 treated with at least 3 months of neoadjuvant chemotherapy
  • All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry

Exclusion Criteria:

  • Patients receiving any anti-cancer therapy (chemotherapy, immunotherapy, and/or biologic therapy) for 8 patients; the other 8 patients will be treated with neoadjuvant chemotherapy but no radiation, biologic or immunotherapy prior to surgery
  • Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
  • Concomitant active malignancy
  • Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Basic science (uniformly-labeled [13C]glucose)

Patients receive uniformly-labeled \[13C\]glucose IV over 10 minutes and then over up to 120 minutes until time of biopsy. Patients then undergo surgery and biopsy per standard of care.

Interventions

Biopsy

Undergo biopsy

Therapeutic Conventional Surgery

Undergo surgery

Uniformly-labeled [13C]glucose

Given IV

Primary outcome measure

  • To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

Recruiting

Livingston, New Jersey, United States, 07039

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Howard S. Hochster

732-235-5912

Principal Investigator:

Howard S. Hochster

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-05-04.